Lennon, Ryan J.

Objectives: To determine the prevalence and relationship of frailty and health status measures among residents of long-term care [nursing homes (NH) and assisted living (AL)] facilities. Resident and methods: Residents ≥ 65 years who are residents of NH and AL facilities at La Crosse county, Wisconsin, were assessed for frailty (gait speed, unintended weight loss, and grip strength), comorbidity (Charlson index), and quality of life (QOL) [Short Form (SF)-36]. Results: Among 96 participants (57 from NH and 39 from AL), 78% were frail. The prevalence of frailty (77% vs. 79%), comorbidity (2.0 vs. 2.0), and poor health status did not differ between residents of NH and AL living facilities. Frail residents were older and had higher comorbidity index (2.0 vs. 0, p=0.02), including diabetes mellitus, hypertension, and heart failure. Frailty had the strongest correlation with the SF-36 Physical Component Score (r=-0.45), Figure. It exhibited weaker associations with comorbidity and the SF-36 Mental Component Score. Overall, SF-36 for physical component was lower among frail residents (33 vs. 48, p<0.001). Following adjustments by linear regression, compared to those without frailty, frail residents had lower adjusted quality of life scores. Conclusion: Frailty was highly prevalent among residents of long-term care facilities and did not differ between NH and AL facilities. We noted significant correlations between frailty, comorbid conditions, and poor quality of life.

Introduction: Thoracic external beam radiation therapy (XRT) for cancer is associated with a multitude of long-term cardiotoxic side effects. Previous studies have suggested worse outcomes in XRT-treated cancer survivors who undergo revascularization with CABG, but sample sizes have been small. In addition, XRT after CABG is thought to portend decreased patency and survival. We aimed to examine outcomes after CABG in patients with XRT compared with to those without XRT. Methods: We identified all patients who were treated with both CABG (between 1999 and 2013) and curative thoracic XRT for cancer (between 1971 and 2013) (>30 Gray). Baseline clinical characteristics and comorbidities at time of CABG, as well as long-term outcomes after CABG and XRT were compared with propensity matched control cohorts. Results: A total of 38 patients underwent CABG following XRT [Group 1] (mean age 67.9, 63% female) and 43 patients underwent XRT after CABG [Group 2] (mean age 69.3, 63% female). Compared with propensity-matched controls (Group 1: n=141; Group 2: n=167), baseline clinical and demographic characteristics between cases and controls were similar in both groups, except a lower incidence of triple vessel disease in XRT cases in Group 2 (64 vs 80%, p=0.02). For Group 1, there was no significant difference in all-cause survival in long-term follow-up after CABG (Fig. 1, p=0.72). Meanwhile, Group 2 cases had significantly higher all-cause mortality following XRT (Fig. 2, p<0.001). Conclusions: Patients previously treated with thoracic XRT who subsequently undergo CABG for coronary artery disease have a similar overall mortality rate compared to patients without prior XRT. This suggests that CABG is an effective method of revascularization in these patients. The higher mortality rates in CABG patients who subsequently develop disease requiring thoracic XRT is likely due to oncologic rather than cardiovascular causes, but more data are necessary to evaluate this finding.

Introduction: Triple oral antithrombotic therapy (TOAT) (aspirin, clopidogrel, and warfarin) is associated with an increased risk of bleeding. Despite this, the optimal management of patients with indications for warfarin following percutaneous coronary intervention (PCI) has not been established. We sought to compare long-term clinical outcomes between patients receiving TOAT with those receiving dual antiplatelet therapy (DAPT) (aspirin and clopidogrel) after PCI. Hypothesis: Patients with clinical indications for warfarin have higher baseline risk which is largely responsible for the observed differences in outcomes between patients receiving TOAT vs. DAPT. Methods: Retrospective analysis of prospectively collected data from 9,009 patients. The primary outcome was a composite of all-cause mortality, ischemic or embolic events (myocardial infarction or stroke), or bleeding. Secondary outcomes were death plus ischemic or embolic events, death plus bleeding, death, MI, stroke, and bleeding. A 2:1 propensity matched analysis was also performed. Results: In 9,009 patients, 812 received TOAT and 8,197 received DAPT. Median follow-up was 61 months. The primary end point occurred in 2,749 patients. At 1 year, 22% of patients treated with TOAT had the primary endpoint versus 11% of DAPT patients (p<0.001). At 1 year, secondary end points of death or ischemic or embolic events (19% vs. 10%, p<0.001), and death or bleeding events (15% vs. 5%, p<0.001) also occurred with a higher frequency with TOAT. After propensity matched analysis the above differences were no longer significant with 1 year primary endpoint rates of 19% vs. 17% respectively (HR 1.95%, CI 0.88, 1.47; p = 0.33). Following propensity matching the only significant difference between TOAT and DAPT groups was minor bleeding (5% vs. 2%; HR 2.65, 95% CI 1.39, 5.03; p=0.003). Conclusions: In a large single center registry with comprehensive follow up, patients treated with TOAT had higher rates of ischemic and bleeding events. However, when baseline risks are accounted for event rates are similar, other than minor bleeding, indicating patient risk characteristics are largely responsible for the observed differences in outcomes.

Background: The presence of frailty increases the risk of long-term mortality for a myriad of reasons, but its association with cardiac-specific mortality among the elderly undergoing percutaneous coronary intervention (PCI) is unknown. We sought to determine the relationship between frailty and cause-specific (cardiac versus non-cardiac) mortality among elderly patients undergoing PCI. Methods: A prospective cohort of elderly (>65 years) patients undergoing PCI at Mayo Clinic between October 2005 and September 2008 were tested for frailty using the Fried criteria. Vital status was prospectively monitored including evaluation of death certificates, telephone interviews and review of autopsy/medical records. Results: Frailty data was obtained in 428 (84%) of 508 elderly patients (median age 74.2 years [SD 6.4, range 65-100]; 59% male). Of these, 92 (21%) patients were frail while 231 (54%) had intermediate frailty and 105(25%) were not frail. Frail patients were older than intermediate and non-frail patients (77.6 vs 74.3 vs 71.0 years; p<0.001) and had more comorbidities (mean Charlson index 4.6 vs 3.9 vs 2.8; p<0.001). There were 113 deaths (26% of cohort) during 5.1 median years of follow-up, of which 77 (68%) were classified as non-cardiac and 36 (32%) which were classified as cardiac. Frailty at baseline was associated with poor overall survival compared to non-frail patients (HR 6.1, 95% CI 3.2, 11.6; p<0.001). The estimated effect of frailty was nearly 3 times greater for cardiac mortality (HR 13.1, 95% CI 3.0, 57.0; p=0.001) than non-cardiac mortality (HR 4.6, 95% CI 2.2, 9.7; p<0.001). These findings remained significant following multivariable adjustment. Conclusions: Frailty is common among elderly patients undergoing PCI and is associated with poor overall survival and both cardiac and non-cardiac causes of death.

Background: Transthoracic echocardiography is the mainstay of cardiac imaging and is highly dependent upon cardiac sonographers for whom image acquisition can be physically demanding and associated with musculoskeletal pain. Prior studies are limited by the absence of adequate control groups and a lack of adjustment for potential confounders. Objectives: The purpose of this study was to determine the prevalence and impact of work-related musculoskeletal pain in cardiac sonographers as compared to a large control group of non-invasive healthcare professionals with similar demographics. Methods: An electronic survey was administered to Mayo Clinic employees identified by human resources at six major patient care facilities in four different states. Results: There were 2682 employees within the departments of cardiology and radiology who were contacted and 1532 (57%) completed the survey. After exclusion of those who wear protective lead aprons, 517 employees comprised the control group and 66 cardiac sonographers made up the study group. Cardiac sonographers and the control group were similar in age, sex, BMI, length of employment and history of prior musculoskeletal pain. Cardiac sonographers reported work-related musculoskeletal pain more frequently than the control group (88% vs 40%; p<0.001). This association persisted after multivariable adjustment for age, sex, body mass index, length of current employment and history of pre-existing musculoskeletal pain (OR 11.6; (95% CI 5.32, 25.5); p<0.001). Cardiac sonographers were more likely to seek medical care for their work-related pain (55% vs 21%; p<0.001) and to have missed work due to pain (35% vs 12%, p<0.001). Conclusions: In this multi-site case control study, cardiac sonographers experienced significantly more work-related pain and missed more work due to pain than a large control group of non-invasive healthcare professionals with similar demographics.

Introduction: Relationship of QOL and frailty are poorly defined. Hypothesis: To study the prevalence and prognosis of poor QOL in frail patients. Methods: Predismissal standardized tests for frailty and QOL in 2 cohorts were administered. In cohort 1, 629 patients ≥ 65 years underwent percutaneous coronary intervention (PCI) from 2005-2008, frailty (Fried) and QOL [SF-36 and SAQ] were ascertained. Cohort 2 [921 patients, 535 PCI, ≥55 years] underwent cardiac catheterization from 2014-18, frailty (Rockwood) and QOL (Likert) were determined. Results: In cohort 1, 19%; and 20% in cohort 2 were frail. Lower median SAQ (58.9 vs. 82.2); physical (29.5 vs. 43.9) and mental (49.2 vs. 57.4) scores of SF-36 in cohort 1 higher rates of fair/poor health (56% vs 18%) in cohort 2 (all comparisons, p<0.001) was seen in frail patients. As compared to without, frail patients were 5 times more likely (59% vs. 11%, p<0.001) in cohort 1 and 7 times more likely (56% vs. 8%) in cohort 2 to have poor QOL. Adjusted three year all-cause death and death/myocardial infarction (MI) was significantly higher for patients undergoing PCI with frailty; [HR (95% CI) death, 4.20 (2.63, 6.68) and death or MI HR 2.72 (1.91, 3.87), p<0.001) and with poor QOL [HR death 2.47 (1.59, 3.84) and death or MI 1.61 (1.16, 2.24) p<0.001). There was no significant interaction between frailty and QOL (p=0.64) indicating their independent prognostic influence. Conclusions: Poor QOL is commonly seen with frailty. Both frailty and poor QOL had significant and independent association with long-term survival.

Abstract Background: Frailty assessment has often been performed only at baseline in cohort studies. Little is known regarding factors associated with changes in frailty indices over follow up in patients with coronary artery disease (CAD). Methods: Between 11/2008 - 8/2012, 142 community-dwelling adults ≥65 years of age with prior history of CAD (angina or revascularization) participated in a study of frailty assessment at Mayo Clinic Health System in La Crosse, WI. A sample of participants (n=45) were included for frailty re-assessment using the Fried frailty criteria approximately 5 years after their baseline measures. Frailty classification was based on absence of deficits (non-frail), 1-2 deficits (intermediately frail), or 3 or more deficits (frail). Factors associated with a change in frailty indices were studied. Results: There were 45 patients that had a second assessment of frailty indices. At baseline, 24 patients (60%) were not frail while 16 patients (40%) had at least 1 frail feature. At follow up, 20 patients (50%) were not frail while 20 patients (50%) had a frail feature. Those improving were more often being married, had prior revascularization, and were without angina. Interval development of slower gait speed (r = 0.46; p=0.004) and decreased grip strength (r = -0.39; p = 0.01) were associated with worsening frailty. Conclusions: Older adults with CAD are not often frail by standard criteria; however, incident deficits develop during long term follow-up. Spousal support, absence of angina, and change in functional indices are less often associated with frailty features.

Abstract Background/Introduction TAILOR-PCI is the largest cardiovascular genotype-based randomized trial (NCT#01742117) investigating whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes after percutaneous coronary intervention (PCI). The TAILOR-PCI Digital Sub-Study tests the feasibility of extending original follow-up of 1 year to 2 years using state-of-the-art digital solutions. Deep phenotyping acquired during a clinical trial can be leveraged by extending follow-up in an efficient and cost-effective manner using digital technology. Purpose Our objective is to describe onboarding and engagement of participants initially recruited in a large, pragmatic, international, multi-center clinical trial to a digital registry. Methods TAILOR-PCI participants, within 23 months of their index PCI, were invited by letters containing a URL to the Digital Sub-Study website (http://tailorpci.eurekaplatform.org). These invitations were followed by phone calls, if no response to the letter, to determine reason for non-participation. A NIH-funded direct-to-participant digital research platform (the Eureka Research Platform) was used to onboard, consent and enroll participants for the digital follow-up. Participants were asked to answer health-related surveys at fixed intervals using the Eureka mobile app and desktop platform. To capture hospitalizations, participants could enable geofencing to allow background location tracking, which triggered surveys if a hospitalization was detected. Result(s) Letters were mailed to 893 of 929 eligible participants across 22 sites in the United States and Canada leading to 226 homepage visits and 118 registrations. There were 107 consents (12.0% of invited; mean age: 66.4±9.0; 19 females [18%]): 47 (44%) participants consented after the letter, 36 (34%) consented after the 1st call and 24 (22%) consented after a 2nd call. Among those who consented, 100 were eligible (7 did not have a smartphone) 81 downloaded the study mobile app and 73 agreed for geofencing (Figure 1). Among the 722 invited participants who were surveyed, 354 declined participation: due to lack of time (146; 20.2%), lack of smartphone (125; 17.3%), difficulty understanding (41; 5.7%), concern about using smartphone (34; 4.7%), concern of data privacy (14; 1.9%), concerns of location tracking (6; 0.8%) and other reasons (57; 7.9%). Conclusion Extended follow-up of a clinical trial using a digital platform is feasible but uptake in this study population was limited largely due to lack of time or a smartphone among participants. Based on data from other digital studies, uptake may also have been limited since digital follow-up consent was not incorporated at the time of consent for the main trial. Figure 1. Onboarding of the digital substudy Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Institute of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)